Bioengineer Process Validation
Posted on Mar 11, 2019 by Celgene
Location: Warren, New Jersey, United States
Work Location: 7 Powder Horn Drive 07059
Employee Status: Full-time
Job Type: Regular
At Celgene Corporation, we re committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. Our Process Development team, part of our Cell Therapy organization, is a highly collaborative, skilled group of individuals who deliver value daily to the production of Celgene s products.
To continue to do this important work, we are hiring a Bioengineer II in Process Validation. Please join us!
What great looks like in this Role
Our ideal Bioengineer is experienced with process development and validation requirements for commercialization of cell and gene therapy or biologics products. You re an excellent communicator and collaborator and can use your skills to motivate others. While this is a technical role in Cellular Process Development group, more emphasis will be placed on stage 1 process validation (Process Design) and process control strategy versus hands-on process development experimentation.
This is a great opportunity to make an impact and interact cross-functionally to achieve results.
Objectives of this Role
- Perform and facilitate completion of process design and characterization deliverables required for commercial filing of cellular therapy products.
- Lead process risk assessments and participate in the authoring of process control strategy documents.
- Work with internal Process Characterization, Process Changes and MSAT Groups (as well as OTLs, outside testing labs, and other third-party service providers) to design and execute experiments and studies as appropriate.
- Support late stage process validation activities (including PPQ).
- Facilitate and lead process risk assessments to drive process control strategies and help prioritize characterization experiments.
- Independently or cooperatively design and execute studies supporting Characterization and Stage 1 Validation, including impurity clearance studies, E&L testing of Drug Product Containers and other single-use systems, administration set characterization, viral clearance studies, particulate evaluations and studies and formal Buffer/Media hold studies.
- Support PPQ design and execution at Celgene and CMOs (Contract Manufacturing Organizations).
- Provide technical and operational input to bioprocess development characterization experiments.
- Establish and qualify impurity clearance assays with internal Analytical/Assay groups and OTLs.
- Contribute to process validation design and execution.
- Write and contribute to process development, process control and process validation documents including strategy documents, test plans and protocols, control and process descriptions, plan summaries, SOPs, regulatory filings etc.
- Present plans and results to other groups.
- Bachelor s degree in biochemical, chemical, or biomedical engineering or cell biology, immunology, chemistry related discipline with 6 - 11 years of relevant experience or master s degree with 4-8 years of relevant experience.
- Excellent verbal, written, and collaboration skills.
- Creativity to define the future of Stage 1 Validation and related deliverables.
- Must have excellent organization skills and the ability to handle multiple tasks.
- Highly motivated, willingness to acquire new skills and ability to work independently.
- Must have strong engineering, statistical, or scientific knowledge appropriate for job requirements.
- Experience in mammalian cell culture and aseptic technique.
- Ability to understand and keep track of regulatory expectations and industry best practices.
- Experience in cell therapy or other breakthrough therapies desired.
- Process control strategy, tech transfer and or process validation experience highly desired.
- Experience working in a regulated environment or with cell therapies would be advantageous.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
\"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Associated topics: biomedical, biophysics, biosynthetic, hereditary, medical, msat, neurodegenerative, nutrition, pain, pharmaceutical